Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

COLUMBUS, Ohio (WCMH) – A Columbus man received a life sentence, plus an additional 65-years in prison, after he was convicted on sex trafficking, drugs and weapons charges. According to federal ...

South Korean medical students who walked out of school last year in protest at a government plan to increase medical school admissions said on Saturday that they would return to campus, calling on ...

JOHN BURNETT / HAWAII TRIBUNE-HERALD Hawaii County Police Chief Benjamin Moszkowicz addresses the Hawaii County Police Commission today in Hilo. A motion to accept the withdrawal of his ...

Capricor Therapeutics Inc. shares tumbled 35% after US regulators rejected the company’s treatment for a deadly muscle disorder. The San Diego-based biotech has been developing a cell therapy for a ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | Although many of the complete response letters uploaded by the FDA this ...

Capricor Therapeutics said the U.S. Food and Drug Administration has rejected its application seeking approval of its lead cell-therapy candidate Deramiocel in the neuromuscular genetic disease ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment continues.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and ...